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The government appears to have prevailed in its bid to ban over 300 Fixed Dose Combinations (FDCs). But in the most inefficient way possible. It has let the problem get out of hand, then fought the industry in more than one court, constituted two different committees to weigh in on the issue and culminated with a relatively small, but valuable, number of drugs from its 2016 list still awaiting further study. In the interim, it has drawn global criticism for its lax attitude towards safety. Read my quick take published yesterday on money control here. The ban comes a decade after the first attempts made to tackle the issue by the then Drugs Controller General of India, and 6 years after a Parliamentary Standing Committee strongly criticised the office of the drugs regulator for jeopardising patient safety.

The offer by needle and syringe manufacturers to voluntarily cap trade margins at 75 per cent after meeting with the National Pharmaceutical Pricing Authority apparently validates the view that without the actionable threat of price control, the healthcare sector cannot be trusted to self-regulate.

“The NPPA advised manufacturers to consider regulating price themselves; otherwise, the government would be forced to take steps as they have done to cap prices in the past for items like stents and orthopaedic implants,” reported the newspaper Mint quoting a person aware of the matter who spoke on condition of anonymity.

I asked, Rajiv Nath, President, AISNMA, the association of homegrown manufacturers that made this offer, in an e-mail : why wait for an NPPA ultimatum? If a cap was implementable, why not just go ahead and do it? I have published responses to these and other queries in their entirety in the interest of clarity. But before that, my take based on these responses and the media coverage on the issue. Continue reading →

The Financial Express published an infographic today that showed that the Indian pharma industry’s turnover from exports was up to 65.8 per cent in FY16 from 57.1 per cent in FY11. The newspaper was quick to lay this at the door of enhanced government price controls though the graphic itself proved no such thing. The government “needs to ponder” over whether this was proving helpful to consumers, it said.

While I’m no great fan of price control as a long-term, sustainable solution for the affordability problem, I felt this claim was not rooted in sufficient research or at least not based on this particular infographic that was being used to back it. You can say a lot of things about India’s price control regime, but if India Pharma is enamoured of exports, price controls are only marginally, if at all, responsible. Continue reading →

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The Dehi High Court has quashed the ban of over 300 fixed dose combinations (FDCs) announced by the Indian government in March this year. This has left health activists and other drug safety proponents sorely disappointed. The Union Ministry of Health’s decision to ban what it termed “irrational” drug combinations – drugs that either need not or should not be combined into a single formulation – counts as one of its most sweeping, and decisive actions on drug safety in recent memory. However, judging by news reports, it appears to have stumbled on procedural grounds – on mere technicalities.

It is in human nature to look for silver linings to clouds. Or at least, it is in mine. So I tweeted that at least many FDCs had gone off the market after this notification. Then, I reckoned to myself that perhaps doctors might now think twice before prescribing dodgy FDCs. And I am sure, there are others thinking, “Well, at least the government tried.” (Including the government itself).

But then, I stopped short and went back and mentally obliterated all the silver linings. For, when it comes to fighting for drug safety, you have to win. Continue reading →

The central government, through the office of the Indian drugs regulator, has done away with the cap on the number of clinical trials per investigator. This is after it was pointed out by clinical research stakeholders such as sponsors and investigators, that this could lead to under-utilisation of clinical trials infrastructure, and investigator expertise.

The decision is now left to the Ethics Committe (EC) of the institution where the trial is to be conducted as was recommended by the Expert Committee set up by the government under the late Ranjit Roy Chaudhury. This is clearly a great relief to those involved in the conduct of clinical trials.

But at the risk of sounding like a wet blanket, I have to say – this sounds suspiciously like one of those on-again, off-again decisions that pretty much leave you where you started off with, wondering what really was achieved. Continue reading →

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Last June, I wrote about the burgeoning online pharmacy business on this blog.

Taking off on a column that I had authored for the Indian Express, I pointed out that while India’s regulation of brick-and-mortar pharmacies (or chemist shops) has been slack, online pharmacies would be held to higher standards. That in the absence of a clear-cut legal pathway for online pharmacies to follow, friction with regulators could not be ruled out. And that these uncertainties would adversely impact e-pharmacies’ ability to raise funds from investors.

At a recent event organised by the Indian Internet Pharmacy Association (IIPA), it became clear that all this and more had come to fruition.

What intrigued me is that the e-pharmacy’s enemy number one appears to be India’s foremost chemist association AIOCD. IIPA members allege that they have had to endure regulatory harassment triggered by complaints from AIOCD members. These complaints have led to police investigations, regulatory raids, and the cancellation of licences of chemist shops supplying Internet pharmacies culminating in the IIPA openly accusing AIOCD members of instigating the administration to launch unnecessary probes against them. And of pressuring those chemists who do supply e-pharmacies to back off. Continue reading →

Clinical trials, that hot-button subject hogging headlines up until a year ago, appears to have quietly slipped into the realm of business-as-usual. However, there are still some knotty issues to be resolved. Chief among them is the oversight of Ethics Committees (ECs) as was evident at a recent event I attended.

ECs – which are a mix of experts and lay persons – are the gatekeepers of ethics within their institutions. Just as a strong EC can blow the whistle on unethical behaviour, a weak or careless one might inadvertently abet it. Continue reading →

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I’ve been quite vocal in my views about the ban on fixed dose combinations on Twitter. So here’s a selection of my key tweets (and some retweets) on the subject. Good way to get a quick summary of the subject while I hem and haw over a longer article (if it ever gets written). Latest tweets on top. Continue reading →

The abnormally high margin that trade channels are believed to earn on a relatively small portion of the Indian pharmaceutical market has become the latest painpoint for the central government. The margins in question even cross 1000 per cent in some cases, according to a new report by a committee set up by the Department of Pharmaceuticals (DoP) in the Union Ministry of Chemicals and Fertilizers to investigate the matter.

The committee has now recommended capping trade margins on not just such meds which go by the moniker of ‘trade generics,’ but all drugs.

A cap on trade margins is not only difficult to implement but will do precious little to lower the price that the consumer pays. It might even lead to disputes and litigation between companies, trade, and the government. Besides, trade generics constitute not more than 15 per cent of the overall pharmaceutical market – and that is an outside estimate. Yet, this is being done in the name of the consumer. Continue reading →